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HomeFocusStudies shoot down 'inflated' statin claims

Studies shoot down 'inflated' statin claims

Hailed as miracle drugs when they hit the market two decades ago, statins are not as effective nor as safe as we have been led to believe, say Dr David M. Diamond, a professor of psychology, molecular pharmacology and physiology at the University of South Florida, and Dr Uffe Ravnskov, an independent health researcher and an expert in cholesterol and cardiovascular disease.

Science Newsline reports that according to Diamond and Ravnskov, statins produce a dramatic reduction in cholesterol levels, but they have "failed to substantially improve cardiovascular outcomes." They further state that the many studies touting the efficacy of statins have not only neglected to account for the numerous serious adverse side effects of the drugs, but supporters of statins have used what the authors refer to as "statistical deception" to make inflated claims about their effectiveness.

Their paper is an analysis of the data in the statin trials which led them to conclude that "statin advocates have used statistical deception to create the illusion that statins are 'wonder drugs,' when the reality is that their modest benefits are more than offset by their adverse effects."

The paper also describes how the basis of the deception is in how authors of the statin studies present the rate of beneficial and adverse effects. The effect of the drugs on the population is called the "absolute risk," which has shown that statins benefit only about 1% of the population. This means that only one out of 100 people treated with a statin will have one less heart attack. Statin researchers, however, don't present the 1% effect to the public. Instead they transform the 1% effect using another statistic, called the "relative risk," which creates the appearance that statins benefit 30-50% of the population. The exaggeration of beneficial effects of statin treatment was illustrated in their analysis of a subset of statin studies, including the Jupiter Trial (Crestor), the Anglo-Scandinavian Cardiac Outcomes Trial Lipid Lowering Arm (ASCOT-LLA), and the British Heart Protection Study.

"In the Jupiter trial, the public and healthcare workers were informed of a 54% reduction in heart attacks, when the actual effect in reduction of coronary events was less than 1 percentage point," said Ravnskov and Diamond. "In the ASCOT-LLA study, which was terminated early because it was considered to have such outstanding results, there were heart attacks and deaths in 3% of the placebo (no treatment) group as compared to 1.9% in the Lipitor group. The improvement in outcome with Lipitor treatment was only 1.1 percentage point, but when this study was presented to the public, the advertisements used the inflated (relative risk) statistic, which transformed the 1.1% effect into a 36% reduction in heart attack risk.

The inflated claims for statin effectiveness, and minimised portrayal of the adverse effects, has played a role in the health care providers and the public's enthusiasm for cholesterol-lowering drugs, say the authors. "The adverse effects suffered by people taking statins are more common than reported in the media and at medical conferences" explains Diamond and Ravnskov. According to the authors, "Increased rates of cancer, cataracts, diabetes, cognitive impairments and musculoskeletal disorders more than offset the modest cardiovascular benefits of statin treatment."

The authors emphasised that low cholesterol levels related to statin use have frequently been associated with an increased risk of cancer. They also noted that most statin trials are terminated within two to five years, a period too short to see most cancers develop. Nevertheless, studies have shown a greater incidence of cancer in people who take statins, and one long-term study demonstrated a dramatic increase in the incidence of breast cancer among women who had used statins for more than 10 years.

They emphasised that the public needs to be wary of conflicts of interest in the medical community and pharmaceutical industry when it comes to touting the benefits of statins and skewing the data in such a way as to make the drugs seem more effective at lowering cardiovascular disease and heart attack risks than they may actually be.

The authors advocate other health beneficial strategies that are known to reduce cardiovascular risk, such as cessation of smoking, weight control, exercise and stress reduction. They also emphasized the great value of a low carbohydrate diet for normalising all of the biomarkers of cardiovascular risk, with excellent outcomes, especially for people with type 2 diabetes.

 

A new study led by researchers at Penn State College of Medicine and National Institute of Environmental Health Sciences found the use of statins may not be associated with lowering risk for Parkinson's disease. The findings cast doubts on reports suggesting that the cholesterol-lowering medications may protect against this neurodegenerative brain disorder.

Although the cause of PD is unknown, damage to dopamine-producing neurons eventually leads to the movement disorders that are a hallmark of the disease. Xuemei Huang, professor of neurology and vice chair for research, Penn State College of Medicine, previously reported an association between high blood cholesterol levels and lower incidence of PD. A low incidence of heart attack and stroke in PD patients in movement disorder clinics, despite their usually advanced age motivated these studies. Other studies also reported similar findings.

However, evidence has been somewhat inconsistent. The use of statins has also been associated with a lower incidence of PD in several recent epidemiology studies, leading some researchers to hypothesise that these medications, which lower levels of LDL – bad cholesterol – may protect against PD. Those studies, however, failed to account for cholesterol levels prior to the widespread use of statins in the US population, Huang said, noting that as a strength of the new study.

The researchers looked at blood cholesterol levels, medications and PD status in participants in the ongoing, long-term Atherosclerosis Risk in Communities study. Cholesterol readings were taken at three-year intervals over the course of a decade from 1987 to 1989, before widespread statin use began.

"We confirmed our previous finding that high total cholesterol and LDL cholesterol were associated with a lower risk of PD," Huang said. "Moreover, statin use over the course of the study did not protect against PD, and in fact appeared to increase PD risk in the long term. Although the analysis on statin use and PD was based on a fairly small number of PD cases, this preliminary data argues against the hypothesis that statins protect against PD."

"One possibility," Huang said, "is that statin use can be a marker of people who have high cholesterol which itself may be associated with lower PD risk. This could explain why some studies have found an association between use of these medications and low incidence of PD. Most importantly, this purported benefit may not be seen over time." Future research should focus on if and why cholesterol may protect against PD.

Although blood cholesterol is not indicative of cholesterol in the brain, there is increasing evidence that PD may begin outside the brain. Statin-induced decreases in blood cholesterol levels may have unknown consequences in these peripheral areas. A compound called co-enzyme Q10 that is produced alongside cholesterol may also be an area of future PD research. Statins reduce co-enzyme Q10, which helps produce energy for cells and is hypothesised to have protective qualities in nerve cells.

"Statins have been proven to be effective in the primary and secondary prevention of cardiovascular events and stroke. Although some have proposed that statins might be a 'cure-all' drug," Huang said, "this might be a case where what's good for the heart isn't good for the brain." Until more epidemiological and basic research can be conducted to further parse out the associations between PD, cholesterol and statins, physicians and scientists should be cautious in promoting health benefits of statins for PD without a good understanding of clinical evidence and potential biological mechanisms, Huang advises. Patients and physicians considering statins for cardiovascular health and stroke prevention should consider their individual cases. "This is evidence that personalised medicine is better than a one-size-fits-all approach," Huang said.

[link url="http://www.sciencenewsline.com/articles/2015022020080039.html"]Full Science Newsline report[/link]
[link url="http://informahealthcare.com/doi/abs/10.1586/17512433.2015.1012494"]Expert Review in Clinical Pharmacology article summary[/link]
[link url="http://news.psu.edu/story/345483/2015/02/19/research/statins-may-not-lower-parkinsons-risk"]Penn State College of Medicine release[/link]
[link url="http://onlinelibrary.wiley.com/doi/10.1002/mds.26152/abstract"]Movement Disorders abstract[/link]

[link url="https://www.medicalbrief.co.za/?s=statins"]Other statins-related material in MedicalBrief archives[/link]

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